Secondary Outcomes

time frame:
From baseline to day 29, weeks 12 and 26 after HAVG implantation.

Development of IgG antibodies

time frame:
From baseline to day 29, weeks 12 and 26 after HAVG implantation.

Graft interventions

time frame:
At each visit, i.e. day 1, day 4-7, day 15, day 29, day 57, week 12, week 16, 20, 26 after HAVG implantation.

HAVG patency rates

time frame:
at 12, 18, 24 months after HAVG implantation.

Eligibility Criteria

Male or female participants from 18 years up to 80 years old.

Inclusion Criteria:
- Patients with ESRD who are not, or who are no longer candidates for creation of an
autologous AV fistula and therefore need placement of an AV graft in the upper
extremity to start or maintain hemodialysis therapy
- Age 18 to 80 years old, inclusive
- Suitable anatomy for implantation of straight forearm grafts or curved upper arm
grafts (arterial anastomosis to radial or brachial artery, venous anastomosis to
either brachial cephalic or very central basilica vein)
- Hemoglobin ≥8 g/dL and platelet count ≥100,000 cells/mm3 prior to Day 1
- Other hematological and biochemical parameters within a range consistent with ESRD
and acceptable for the administration of general anesthesia prior to Day 1
- Adequate liver function, defined as serum bilirubin ≤1.5 mg/dL; GGT, AST, ALT, and
alkaline phosphatase ≤2x upper limit of normal or international normalized ratio
(INR) ≤1.5 prior to Day 1.
- Able to communicate meaningfully with investigative staff, competent to give written
informed consent, and able to comply with entire study procedures
- Able and willing to give informed consent
- Life expectancy of at least 1 year
Exclusion Criteria:
- History or evidence of severe cardiac disease (NYHA Functional Class III or IV),
myocardial infarction within 6 months of study entry (Day 1), ventricular
tachyarrhythmias requiring continuing treatment, or unstable angina
- Uncontrolled or poorly controlled diabetes; hospitalization for poor glucose control
within the previous 6 months is an absolute exclusion criterion
- History or evidence of severe peripheral vascular disease in the upper limbs
- Known or suspected central vein obstruction on the side of planned graft implantation
- Stroke within 6 months of study entry (Day 1)
- Candidate for renal transplantation
- Treatment with any investigational drug or device within 60 days prior to study entry
(Day 1)
- Treatment with vitamin K-antagonists, factor Xa inhibitors, or direct thrombin
inhibitors within the month prior to study entry (Day 1)
- Female patients who are pregnant, intending to become pregnant, nursing or intending
to nurse during the study
- Female patients of child bearing potential (not surgically sterile or at least 2
years post menopause) who do not use a highly effective method of birth control
(failure rate less than 1% per year when used consistently and correctly), eg,
implants, injectables, combined oral contraceptives in combination with a barrier
method, some intrauterine contraceptive devices, sexual abstinence, or a vasectomized
partner
- History of cancer with active disease or treatment within the previous year
- Immunodeficiency including AIDS / HIV
- Documented hypercoagulable state or history of 2 or more DVTs or other spontaneous
intravascular thrombotic events (thromboses of previous dialysis accesses do not
count)
- Bleeding diathesis
- Active clinically significant autoimmune disease
- History of heparin-induced thrombocytopenia
- Previous PTFE graft in the operative limb unless the HAVG can be placed more
proximally than the previous failed graft
- More than 1 failed PTFE graft in the operative limb
- Active local or systemic infection (WBC > 15,000 cells/mm3)
- Patients receiving a forearm graft with which crosses the elbow
- Patients receiving an upper arm graft with arterial anastomosis to the axillary
artery or venous anastomosis to the axillary vein unless low in the axilla and
accessible for ultrasound monitoring and compression
- Patients receiving a lower extremity AV access
- Known serious allergy to aspirin
- Any other condition which in the judgment of the investigator would preclude adequate
evaluation of the safety and efficacy of the HAVG
- Previous enrollment in this study
- Employees of the sponsor or patients who are employees or relatives of the
investigator

Additional Information

Official title

A Phase I Study for the Evaluation of Safety and Efficacy of Humacyte's Human Acellular Vascular Graft for Use as a Vascular Prosthesis for Hemodialysis Access in Patients With End-Stage Renal Disease

Description

The HAVG is a sterile, non-pyrogenic, acellular tubular graft composed of human collagens
and other natural extra-cellular matrix proteins. Upon implantation, it is anticipated
(based on pre-clinical studies) that the collagen-based matrix comprising the graft will be
infiltrated with host cells and re-modeled by the host. This will result in a vascular
structure more similar to the histological composition of the native vascular tissue that
may improve graft longevity and be less likely to become infected.

Trial information was received from ClinicalTrials.gov and was last updated in August 2016.